(168 days)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.
This document describes the declaration of equivalency for a Surgical Face Mask. There is no information regarding AI/ML device in this document. Therefore, I cannot provide an answer based on the given document.
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June 4, 2021
Juntech(Jiaxing)Healthcare Materials Co,.Ltd % Gamma Zhang RA Manager Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, Guangdong 510000 China
Re: K203704
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 5, 2021
Dear Gamma Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203704
Device Name Surgical Face Mask
Indications for Use (Describe)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) Summary
This 510(k) Summary is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Juntech (Jiaxing) Healthcare Materials Co,.Ltd |
|---|---|
| Address: | No.4 Plant, No1 build of North of Yubei St, and Zhengdong Rd,Yuxin Town Nanhu District, Jiaxing Zhejiang, China |
| Contact person: | Cam Sun |
| Phone number: | 86-573-83178618 |
| Fax number: | 86-573-83178620 |
| Email: | cam.sun@juntai-tech.com |
| Date of summary prepared: | 2021-04-27 |
(2) Proprietary name of the device
| Trade name: | Surgical Face Mask |
|---|---|
| Regulation name: | Surgical apparel |
| Regulation number: | 21 CFR 878.4040 |
| Product code: | FXX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(3) Predicate device
| Sponsor | V&Q Manufacturing Corporation |
|---|---|
| Device Name | Face Mask, Surgical Mask, Surgical Face Mask |
| 510(k) Number | K173062 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |
(4) Description/ Design of device
Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.
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(5) Indications for use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
(6) Materials
| Component of | Material of | Body Contact Category(ISO 10993-1) | Contact Duration (ISO10993-1) |
|---|---|---|---|
| Device Requiring | Component | ||
| Biocompatibility | |||
| Surgical Face Mask | Spunbondpolypropylene,meltblownpolypropylene,urethane elasticfiber, Steel wirecovered by PPcovering. | Surface-contactingdevice: skin | Prolonged contact: 24 hoursto 30 day |
The body-contacting material used in the Surgical Face Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".
(7) Technological Characteristics Comparison Table
| Item | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Trade name | Surgical Face Mask | Non Woven Face Mask | / |
| 510 (k) number | K203704 | K173062 | / |
| Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Regulation description | Surgical apparel | Surgical apparel | Same |
| Product code | FXX | FXX | Same |
| Class | II | II | Same |
| Indications for use/ Intended use | Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood | Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against | Same |
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| and body fluids, and | transfer of | ||||
|---|---|---|---|---|---|
| particulate materials. | microorganisms,blood and body fluids,andparticulate materials. | ||||
| Innerlayer | Spun-bondpolypropylene | Spun-bondpolypropylene | Similar. All the materials ofTargeted device are used inPredicate device. | ||
| Middlelayer | Meltblownpolypropylene | Meltblownpolypropylene | |||
| Materials | Outerlayer | Spun-bondpolypropylene | Spun-bondpolypropylene | ||
| Nosepiece | Steel wire covered byPP covering | White aluminum stripwith PP covering | |||
| Headband | Urethane elastic fiber | Urethane elastic fiberor spun-bondpolypropylene | |||
| Mask style | Flat pleated | Flat pleated | Same | ||
| Design feature | Earloop | Earloop or tie-on | Same | ||
| Dimensions | 17.5cm*9cm | 175mm×95mm | Same | ||
| Latex | Not made with naturalrubber latex | Not made with naturalrubber latex | Same | ||
| Color | Blue (outer layer) andwhite (inner layer) | Blue (outer layer) andwhite (inner layer) | Same | ||
| Performance test result | |||||
| PerformanceTesting (ASTMF2100-19) | Level 3 | Level 2 | Different. Note 1 | ||
| Fluid resistance | 3 non-consecutive lots,1st lot: 30 of 32samples >99.9% at 0.1µmpass at 160 mmHg;2nd lot: 29 of 32 samplespass at 160mmHg;3rd lot: 29 of 32samples >99.9% at 0.1µmpass at 160mmHg | Pass at 120 mmHg | Similar. Targeted device meetsASTM F2100-19Requirements for Level3 Classification and ISO 22609:≥29 of 32 test articles pass at160 mmHg | ||
| Particle FiltrationEfficiency | 3 non-consecutive lots,1st lot: 32samples >99.9% at0.1 μm; | Average 99.74%at 0.1 µm | Similar. Targeted device meetsASTM F2100-19Requirements for Level3 Classification: ≥98% at 0.1µm |
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| samples >99.9% at0.1μm;3rd lot: 32samples >99.9% at 0.1µm | |||
|---|---|---|---|
| BacterialFiltrationEfficiency | 3 non-consecutive lots,1st lot: 32samples >99.9%;2nd lot: 32samples >99.9%;3rd lot: 32samples >99.9% | 99.4% | Similar. Targeted device meetsASTM F2100-19Requirements for Level3 Classification: ≥98% |
| FlammabilityClass | 3 non-consecutive lots,Each lot: 32 samples:Class 1 | Class 1 | Similar. Targeted device meetsASTM F2100-19Requirements for Level3 Classification: Class 1 |
| Delta – P | 3 non-consecutive lots,1st lot: 4.1 to 4.5 mmH2O/cm2;2nd lot: 4.0 to 4.6 mmH2O/cm2;3rd lot: 3.7 to 3.9 mmH2O/cm2 | Average mmH2O/cm2 | 2.7 Similar. Targeted device meetsASTM F2100-19Requirements for Level3 Classification: <6 mmH2O/cm2 |
| Biocompatibility | Under the conditions ofthe study, the devicewas found non-cytotoxic", "non-irritating", or"non-sensitizing | Under the conditionsof the study, thedevice was foundnon-cytotoxic","non-irritating", or"non-sensitizing | Same |
A Note 1:
The surgical masks are divided into three levels against ASTM F2100-19 which Level 3 Barrier is the most demanding. Performance testing was provided in support of that the Surgical Face Mask meets ASTM F2100-19 Requirements for Level 3 Classification.
(8) Summary for Non-clinical Studies
The performance tests of Non Woven Face Mask were conducted.
- A ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- A ASTM F1862 Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- A ASTM F 2101-14 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
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Juntech (Jiaxing) Healthcare Materials Co,. Ltd - K203704
-
MIL-M-36954C Military Specification - Mask, Surgical, Disposable
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES >
During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.
- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
| Test Methodology | Purpose | AcceptanceCriteria | Results | |
|---|---|---|---|---|
| Performance Testing(ASTMF2100-19) | To test the fluidresistance, particlefiltration efficiency,bacterial filtrationefficiency, flammabilityclass, DifferentialPressure of Surgical FaceMask | Level 3 | Level 3 | |
| Fluid resistance | To evaluate surgicalfacemasks and other typesof protective clothingmaterials designed toprotect against fluidpenetration, as well assimulate an arterial sprayand evaluate theeffectiveness of the testarticle in protecting theuser from possibleexposure to blood andother body fluids. | Per ASTM F1862and ISO 22609, anacceptable qualitylimit of 4.0% ismet for a normalsinglesampling planwhen ≥29 of 32test articles showpassing results. | 3 non-consecutive lots,1st lot: 30 of 32 samples>99.9% at 0.1μm pass at160 mmHg;2nd lot: 29 of 32 samplespass at 160mmHg;3rd lot: 29 of 32 samples>99.9% at 0.1μm pass at160mmHg | |
| Particle FiltrationEfficiency | To evaluate the non-viableparticle filtrationefficiency (PFE) of thetest article | ≥98% at 0.1μm | 3 non-consecutive lots,1st lot: 32 samples>99.9% at 0.1μm;2nd lot: 32 samples>99.9% at 0.1μm;3rd lot: 32 samples>99.9% at 0.1μm | |
| Bacterial FiltrationEfficiency | To determine the filtrationefficiency of test articlesby comparingthe bacterial controlcounts upstream of thetest article to the bacterialcounts downstream. | ≥98% | 3 non-consecutive lots,1st lot: 32 samples>99.9% at 0.1μm;2nd lot: 32 samples>99.9% at 0.1μm;3rd lot: 32 samples>99.9% at 0.1μm | |
| Flammability Class | To evaluate theflammability of plainsurface clothing textilesby measuring the ease ofignition and the speed offlame spread. | Class 1 | 3 non-consecutive lots,Each lot: 32 samples:Class 1 | |
| Delta - P | To determine the | <6 mmH2O/cm2 | 3 non-consecutive lots, | |
| BiocompatibilityISO 10993-5 and ISO10993-10 | breathability of testarticles by measuring thedifferential air pressure oneither side of the testarticle using a manometer,at a constant flow rate. | To test In VitroCytotoxicity, Irritationand Skin Sensitization ofSurgical Medical Mask | non-cytotoxic","non-irritating", or“non-sensitizing | 1st lot: 4.1 to 4.5 mmH2O/cm2;2nd lot: 4.0 to 4.6 mmH2O/cm2;3rd lot: 3.7 to 3.9 mmH2O/cm2Under the conditions ofthe study, the device wasfound non-cytotoxic","non-irritating", or"non-sensitizing |
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(9) Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203704, Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K173062.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.